The joint application between Regenetek Therapies and CCSVI Clinic has been approved through the IEC Institutional Review Board (IRB) that will allow researchers to use patient data to study their new extended and enhanced aftercare treatment protocol. The study hypothesis states that in MS patients with CCSVI undergoing endovascular treatment, those receiving the enhanced hospital aftercare protocol will have an improved long-term outcome over those patients not receiving this same protocol. The study is a Prospective, Longitudinal, Cohort Study in which patients are given the enhanced hospital aftercare and post-procedure protocol and then followed at regular 3 month intervals post-procedure, with the same measurements including symptoms and clinical examination, EDSS scale, Quality of Life Scale (QOL) and Doppler U/S.
Dr. Anand Alurkar, an Interventional Radiologist has done thousands of Intra and Extra cranial angio-procedures over the past 10 years. His previous studies may indicate that it’s critical to position and movement control patients who have had a venous angioplasty post-procedure, monitor them for days afterward with various imaging techniques, for other symptoms of restenosis, and re-treat if necessary. Previously unpublished data for patients who have had venous angioplasty may support a much lower restenosis rate (< 20%) in non-MS patients with the same neck vein blockages, (while conventional liberation treatments of MS patients who undergo the procedure are treated mostly as outpatients) have a restenosis rate of over 50% (at 400 days). Currently, this means that over half of all of the MS patients who get the liberation therapy can expect to be looking to get the procedure done again within a year or so, which would not be considered a successful outcome. This may also be the biggest hurdle to overcome in getting the liberation therapy approved in North America short of clinical trials. If the positive effects of the liberation procedure disappear in many patients after only a few months, it would be reasonable to assume they are placebo unless data is collected to show otherwise. Apart from confirming restenosis rates, the study will establish whether it’s just as important to observe a strict protocol after the procedure for a period of up to 10 days to prevent restenosis. Dr. Alurkar, an Interventional Neurosurgeon involved in the study says “If our daily Doppler Ultrasounds post-procedure come up with anomalies that indicate the beginnings of restenosis in the veins, we’ll take them back and do another balloon angioplasty where the occlusion is starting to occur. It should be no different for MS patients than the non-MS patients but the key is really that they be position controlled, movement controlled, and then monitored for 10 days afterwards to be sure”.
Dr. Don Simonson, the Principal Investigator for the study agrees; “Of course there are other reasons that patients restenose, depending on the condition of their veins in the first place, and operator inexperience, so we have designed a study that isolates the aftercare protocol because we feel it may be at least as important, and in any case well worth studying.”
CCSVI Clinic is already sponsoring patients for this protocol with a 10-day stay in the hospital where patients will be imaged daily, post procedure. If there is evidence of re-occlusion, they will be taken back to the OR and re-treated. To comply with the IRB approval, once home, patients will be examined and/or surveyed at regular intervals by a Principle Investigator (PI) for several years after the treatment to study the changes. Patients will have regular consults with the surgeon who performed their procedure as part of the protocol.
More and more MS patients are reporting initial success (including vascular and some neurological differences) as a result of the venous angioplasty (liberation therapy) but then regression to previous symptoms sometimes within weeks post-procedure. It is estimated that the failure rate of the “liberation therapy” may be 50% or higher, even through the most experienced and best-known surgeons. Consequently, there is increasing concern amongst patients that the liberation therapy hypothesis needs to include a post-procedure protocol that is more refined than simply releasing the patient from the hospital or clinic within hours or a day of the procedure. If the study hypothesis is correct, it means that there are many other considerations that indicate a post-procedure stabilization period, re-examination, and re-treatment if necessary.
A recent intake of Canadian patients confirmed that they were most satisfied with the protocol. “I am convinced that CCSVI Clinic has been by far the best choice available”, says Nicole Magnan, speaking on behalf of her husband, Robert who underwent the therapy under the 10-day protocol. “And nobody in this world that can convince me otherwise. Robert came in here a broken man. He had no hope. His next step was the nursing home. Today he is walking with the aid of a walker and with consistent daily physiotherapy he will make more steps every day. Most importantly, we are hoping that the positive changes will be permanent and the doctors at CCSVI Clinic explained that. They are such special people that will remain in our hearts forever.”
Regular research updates will be published on the CCSVI Clinic website. Questions may be directed toward the CCSVI Clinic administration at 1-888-419-6855. Persons wishing to participate in the study must agree to the informed consent process, qualify through an inclusionary and exclusionary process and agree to be followed for several years by the study research team. They must be prepared to travel to CCSVI Clinicl in Pune, India, but all arrangements will be taken care of by staff associated with the study. Interested persons should ensure that applications are in as soon as possible since there are limitations on the funding for the study population.